FDA recalls inspectors as shutdown drags on; Gottlieb calls PDUFA most ‘vulnerable’

FDA recalls inspectors as shutdown drags on; Gottlieb calls PDUFA most ‘vulnerable’

With the government shutdown now in its fourth week—the longest ever—FDA Commissioner Scott Gottlieb, M.D., says about 400 staff have been recalled to restart inspections, with most of those targeted at drug, biologics and device inspections.

Gottlieb said in a series of Tweets on Tuesday that because of the holidays very few, if any, inspections have been missed and that scheduling picked up on Tuesday. Gottlieb, who has taken on the role of media director since other staff is furloughed, said user fee-supported programs are using carryover fees to keep operating but some, including the PDUFA program, are nearing the end of the till.

“Behind the collective dedication of our professional staff in our inspectorate and our programs, we’re focused on the core aspects of our consumer protection role,” Gottlieb said. “This is requiring hard operational decisions. We’re focused on preserving the function of our programs for as long as we can. We’re closely monitoring the burn rates of all of our user programs, but we’re the most concerned about the PDUFA balances, which have the lowest runway.”

PDUFA is our most vulnerable program and will run out of money first. We’ll get into February but how far into Feb is still very fluid. We’re trying to free resources to extend its runway. We said 4/5 weeks counting this week. That could change but is our rough estimate right now

He said about 260 of the 400 recalled employees are handling medical product inspections, 90 for biologics, 70 for drugs and 100 for medical devices. The other 140 are food inspectors and support staff.

The government shutdown began Dec. 22, when new funding was not approved because of a fight between President Trump and congressional Democrats who took control of the House in the midterm elections. Trump is insisting that funding bills include $5.7 billion for a wall along the border with Mexico. Democrats have refused to approve that, saying the president is just trying to force through an unrealistic campaign pledge and that border security money would be better spent on technology.

An indication of the impact of the shutdown can been seen on the FDA Warning Letters site. While postings are always affected by the end-of-the-year holidays, the last warning letter posted was in early December.

Other agencies like the aviation administration and the IRS were also calling in unpaid workers to handle critical functions and get ready for the 2019 tax season, Politico reported, saying it was hard to get exact numbers because most federal media personnel have been furloughed during the shutdown.

Gottlieb gave credit to field staff for the efforts to keep the agency operating during the shutdown.

“This was a major functional accomplishment amidst one of the biggest operational challenges in FDA’s modern history and it was fully enabled by the leadership of FDA’s field force and the colleagues who serve the country on the front lines of that mission,” he said.

Jan 16, 2019

https://www.fiercepharma.com/

January 17, 2019 / Pharma News